US FDA requests data on 25 high-risk device types on the market since 1976

The US Food and Drug Administration has told manufacturers of certain types of high-risk medical devices that have been on the market since 1976 – before such devices were subject to a rigorous premarket approval process to establish safety and effectiveness – to submit additional information about their products¹. High-risk (Class III) medical devices that have since been approved by the FDA on the basis of being substantially equivalent to these pre-1976 device types are also covered by the new order.